9322 Federal Register / Vol. 78, No. 27 / Friday, February 8, 2013 / Rules and Regulations 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2010–0916; FRL–9376–9] 

Hexythiazox; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of hexythiazox in 

or on alfalfa and timothy. Gowan 

Company requested these tolerances 

under the Federal Food, Drug, and 

Cosmetic Act (FFDCA). 

DATES: This regulation is effective 

February 8, 2013. Objections and 

requests for hearings must be received 

on or before April 9, 2013, and must be 

filed in accordance with the instructions 

provided in 40 CFR part 178 (see also 

Unit I.C. of the SUPPLEMENTARY

INFORMATION). 

ADDRESSES: The docket for this action, 

identified by docket identification (ID) 

number EPA–HQ–OPP–2010–0916, is 

available at http://www.regulations.gov 

or at the Office of Pesticide Programs 

Regulatory Public Docket (OPP Docket) 

in the Environmental Protection Agency 

Docket Center (EPA/DC), EPA West 

Bldg., Rm. 3334, 1301 Constitution Ave. 

NW., Washington, DC 20460–0001. The 

Public Reading Room is open from 8:30 

a.m. to 4:30 p.m., Monday through 

Friday, excluding legal holidays. The 

telephone number for the Public 

Reading Room is (202) 566–1744, and 

the telephone number for the OPP 

Docket is (703) 305–5805. Please review 

the visitor instructions and additional 

information about the docket available 

at http://www.epa.gov/dockets. 

FOR FURTHER INFORMATION CONTACT: Olga 

Odiott, Registration Division (7505P), 

Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; telephone number: 

(703) 308–9369; email address: 

odiott.olga@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this action apply to me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. The following 

list of North American Industrial 

Classification System (NAICS) codes is 

not intended to be exhaustive, but rather 

provides a guide to help readers 

determine whether this document 

applies to them. Potentially affected 

entities may include: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

B. How can I get electronic access to 

other related information? 

You may access a frequently updated 

electronic version of EPA’s tolerance 

regulations at 40 CFR part 180 through 

the Government Printing Office’s e-CFR 

site at http://www.ecfr.gov/cgi-bin/textidx?&c=ecfr&tpl=/ecfrbrowse/Title40/ 

40tab_02.tpl. If OCSPP test guidelines 

are cited, insert the following: To access 

the OCSPP test guidelines referenced in 

this document electronically, please go 

to http://www.epa.gov/ocspp and select 

‘‘Test Methods and Guidelines.’’ 

C. How can I file an objection or hearing 

request? 

Under FFDCA section 408(g), 21 

U.S.C. 346a, any person may file an 

objection to any aspect of this regulation 

and may also request a hearing on those 

objections. You must file your objection 

or request a hearing on this regulation 

in accordance with the instructions 

provided in 40 CFR part 178. To ensure 

proper receipt by EPA, you must 

identify docket ID number EPA–HQ– 

OPP–2010–0916 in the subject line on 

the first page of your submission. All 

objections and requests for a hearing 

must be in writing, and must be 

received by the Hearing Clerk on or 

before April 9, 2013. Addresses for mail 

and hand delivery of objections and 

hearing requests are provided in 40 CFR 

178.25(b). 

In addition to filing an objection or 

hearing request with the Hearing Clerk 

as described in 40 CFR part 178, please 

submit a copy of the filing (excluding 

any Confidential Business Information 

(CBI)) for inclusion in the public docket. 

Information not marked confidential 

pursuant to 40 CFR part 2 may be 

disclosed publicly by EPA without prior 

notice. Submit the non-CBI copy of your 

objection or hearing request, identified 

by docket ID number EPA–HQ–OPP– 

2010–0916, by one of the following 

methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the online 

instructions for submitting comments. 

Do not submit electronically any 

information you consider to be 

Confidential Business Information (CBI) 

or other information whose disclosure is 

restricted by statute. 

• Mail: OPP Docket, Environmental 

Protection Agency Docket Center (EPA/ 

DC), (28221T), 1200 Pennsylvania Ave. 

NW., Washington, DC 20460–0001. 

• Hand Delivery: To make special 

arrangements for hand delivery or 

delivery of boxed information, please 

follow the instructions at http:// 

www.epa.gov/dockets/contacts.htm. 

Additional instructions on commenting 

or visiting the docket, along with more 

information about dockets generally, is 

available at http://www.epa.gov/ 

dockets. 

II. Summary of Petitioned-For 

Tolerance 

In the Federal Register of March 14, 

2012 (77 FR 15012) (FRL–9335–9), EPA 

issued a document pursuant to FFDCA 

section 408(d)(3), 21 U.S.C. 346a(d)(3), 

announcing the filing of a pesticide 

petition (PP 1F7934) by Gowan 

Company, 370 South Main Street, 

Yuma, AZ 85364. The petition 

requested that 40 CFR 180.448 be 

amended by establishing tolerances for 

residues of the insecticide hexythiazox 

(trans-5-(4-chlorophenyl)-N-cyclohexyl4-methyl-2-oxothiazolidine-3- 

carboxamide) and its metabolites 

containing the (4-chlorophenyl)-4- 

methyl-2-oxo-3-thiazolidine moiety, in 

or on wheat, forage at 3.0 parts per 

million (ppm); wheat, hay at 30 ppm; 

wheat, grain at 0.02 ppm; wheat, straw 

at 7.0 ppm; alfalfa, forage at 7.0 ppm; 

alfalfa, hay at 14 ppm; timothy, forage 

at 35 ppm; and timothy, hay at 17 ppm. 

That document referenced a summary of 

the petition prepared by Gowan 

Company, the registrant, which is 

available in the docket, http:// 

www.regulations.gov. There were no 

comments received in response to the 

notice of filing. 

Based on EPA’s review of the data 

supporting the petition, Gowan 

Company revised their petition (PP 

1F7934) as follows: 

i. By increasing the proposed 

tolerances for alfalfa, forage; alfalfa, hay; 

timothy forage; and timothy, hay; 

ii. By deleting the proposed tolerances 

for wheat commodities; 

iii. By adding a request for an increase 

in the established tolerances for cattle, 

fat; goat, fat; horse fat; sheep fat; and 

milk; 

iv. By adding a request for an increase 

in the established tolerances for cattle 

meat byproducts; goat, meat byproducts; 

horse, meat byproducts; and sheep, 

meat byproducts; and; 

v. By proposing tolerances for poultry, 

fat; and poultry, meat byproducts; and 

egg. 

The reasons for these changes are 

explained in Unit IV.D. 


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III. Aggregate Risk Assessment and 

Determination of Safety 

Section 408(b)(2)(A)(i) of FFDCA 

allows EPA to establish a tolerance (the 

legal limit for a pesticide chemical 

residue in or on a food) only if EPA 

determines that the tolerance is ‘‘safe.’’ 

Section 408(b)(2)(A)(ii) of FFDCA 

defines ‘‘safe’’ to mean that ‘‘there is a 

reasonable certainty that no harm will 

result from aggregate exposure to the 

pesticide chemical residue, including 

all anticipated dietary exposures and all 

other exposures for which there is 

reliable information.’’ This includes 

exposure through drinking water and in 

residential settings, but does not include 

occupational exposure. Section 

408(b)(2)(C) of FFDCA requires EPA to 

give special consideration to exposure 

of infants and children to the pesticide 

chemical residue in establishing a 

tolerance and to ‘‘ensure that there is a 

reasonable certainty that no harm will 

result to infants and children from 

aggregate exposure to the pesticide 

chemical residue * * *.’’ 

Consistent with FFDCA section 

408(b)(2)(D), and the factors specified in 

FFDCA section 408(b)(2)(D), EPA has 

reviewed the available scientific data 

and other relevant information in 

support of this action. EPA has 

sufficient data to assess the hazards of 

and to make a determination on 

aggregate exposure for hexythiazox 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with hexythiazox follows. 

A. Toxicological Profile 

EPA has evaluated the available 

toxicity data and considered its validity, 

completeness, and reliability as well as 

the relationship of the results of the 

studies to human risk. EPA has also 

considered available information 

concerning the variability of the 

sensitivities of major identifiable 

subgroups of consumers, including 

infants and children. The toxicity 

database for hexythiazox is complete. 

Hexythiazox has low acute toxicity by 

the oral, dermal and inhalation routes of 

exposure. It produces mild eye 

irritation, is not a dermal irritant, and is 

negative for dermal sensitization. 

Hexythiazox is associated with toxicity 

of the liver and adrenals following 

subchronic and chronic exposure to 

dogs, rats and mice, with the dog being 

the most sensitive species. The prenatal 

developmental studies in rabbits and 

rats and the two-generation 

reproduction study in rats showed no 

indication of increased susceptibility to 

in utero and/or postnatal exposure to 

hexythiazox. Reproductive toxicity was 

not observed. There is no concern for 

immunotoxicity or neurotoxicity 

following exposure to hexythiazox. The 

toxicology database for hexythiazox 

does not show any evidence of 

treatment-related effects on the immune 

system. Hexythiazox is classified as 

‘‘likely to be carcinogenic to humans’’; 

however, the evidence as a whole is not 

strong enough to warrant a quantitative 

estimation of human risk. Since the 

effects seen in the study that serves as 

the basis for the chronic RfD occurred 

at doses substantially below the lowest 

dose that induced tumors, the chronic 

RfD is considered protective of all 

chronic effects including potential 

carcinogenicity. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by hexythiazox as well as 

the no-observed-adverse-effect-level 

(NOAEL) and the lowest-observedadverse-effect-level (LOAEL) from the 

toxicity studies can be found at http:// 

www.regulations.gov in document 

‘‘Hexythiazox. Human Health Risk 

Assessment to Support New Uses on 

Alfalfa and Timothy’’ in docket ID 

number EPA–HQ–OPP–2010–0916. 

B. Toxicological Points of Departure/ 

Levels of Concern 

Once a pesticide’s toxicological 

profile is determined, EPA identifies 

toxicological points of departure (POD) 

and levels of concern to use in 

evaluating the risk posed by human 

exposure to the pesticide. For hazards 

that have a threshold below which there 

is no appreciable risk, the toxicological 

POD is used as the basis for derivation 

of reference values for risk assessment. 

PODs are developed based on a careful 

analysis of the doses in each 

toxicological study to determine the 

dose at which no adverse effects are 

observed (the NOAEL) and the lowest 

dose at which adverse effects of concern 

are identified (the LOAEL). Uncertainty/ 

safety factors are used in conjunction 

with the POD to calculate a safe 

exposure level—generally referred to as 

a population-adjusted dose (PAD) or a 

reference dose (RfD)—and a safe margin 

of exposure (MOE). For non-threshold 

risks, the Agency assumes that any 

amount of exposure will lead to some 

degree of risk. Thus, the Agency 

estimates risk in terms of the probability 

of an occurrence of the adverse effect 

expected in a lifetime. For more 

information on the general principles 

EPA uses in risk characterization and a 

complete description of the risk 

assessment process, see http:// 

www.epa.gov/pesticides/factsheets/ 

riskassess.htm. 

A summary of the toxicological 

endpoints for hexythiazox used for 

human risk assessment is shown in 

Table 1 of this unit. 

TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR HEXYTHIAZOX FOR USE IN HUMAN HEALTH RISK

ASSESSMENT

Exposure/scenario 

Point of departure and 

uncertainty/safety 

factors 

RfD, PAD, LOC for 

risk assessment Study and toxicological effects 

Acute dietary (All populations).No risk is expected from this exposure scenario as no hazard was identified in any toxicity study for this duration of exposure. 

Chronic dietary (All 

populations).

NOAEL = 2.5 mg/kg/ 

day.

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Chronic RfD = 0.025 

mg/kg/day.

cPAD = 0.025 

One-Year Toxicity Feeding Study—Dog. 

LOAEL = 12.5 mg/kg/day based on increased absolute and relative 

adrenal weights and associated adrenal histopathology. 

Incidental oral shortterm (1 to 30 days) 

and intermediateterm (1 to 6 months).

NOAEL = 30 mg/kg/ 

day.

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

LOC for MOE = 100 ... 2-Generation Reproduction Study—Rat. 

LOAEL = 180 mg/kg/day based on decreased pup body weight during lactation and delayed hair growth and/or eye opening, and decreased parental body-weight gain and increased absolute and 

relative liver, kidney, and adrenal weights. 


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TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR HEXYTHIAZOX FOR USE IN HUMAN HEALTH RISK

ASSESSMENT—Continued 

Exposure/scenario 

Point of departure and 

uncertainty/safety 

factors 

RfD, PAD, LOC for 

risk assessment Study and toxicological effects 

13-Week Oral Toxicity Study—Rat. 

NOAEL = 5.5 mg/kg/day. 

LOAEL = 38 mg/kg/day, based on increased absolute and relative 

liver weights in both sexes, increased relative ovarian and kidney 

weights, and fatty degeneration of the adrenal zona fasciculata. 

@ 397.5/257.6 mg/kg/day, decreased body-weight gain in females, 

slight swelling of hepatocytes in central zone (both sexes), increased incidence of glomerulonephrosis in males, increased adrenal weights. 

Cancer (oral, dermal, 

inhalation).

Classification: ‘‘Likely to be Carcinogenic to Humans’’. Insufficient evidence to warrant a quantitative estimation of 

human risk using a cancer slope factor based on the common liver tumors (benign and malignant) observed only in 

high dose female mice, and benign mammary gland tumors of no biological significance, observed only in high dose 

male rats in the absence of mutagenic concerns. The chronic RfD is protective of all chronic effects including potential 

carcinogenicity of hexythiazox. 

FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level of concern. mg/kg/day = 

milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-level. PAD = population adjusted dose (a = acute, c = 

chronic). RfD = reference dose. UF = uncertainty factor. UFA = extrapolation from animal to human (interspecies). UFH = potential variation in 

sensitivity among members of the human population (intraspecies). 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to hexythiazox, EPA 

considered exposure under the 

petitioned-for tolerances as well as all 

existing hexythiazox tolerances in 40 

CFR 180.448. EPA assessed dietary 

exposures from hexythiazox in food as 

follows: 

i. Acute exposure. Quantitative acute 

dietary exposure and risk assessments 

are performed for a food-use pesticide, 

if a toxicological study has indicated the 

possibility of an effect of concern 

occurring as a result of a 1-day or single 

exposure. No such effects were 

identified in the toxicological studies 

for hexythiazox; therefore, a quantitative 

acute dietary exposure assessment is 

unnecessary. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used the food consumption data 

from the USDA 2003–2008 National 

Health and Nutrition Examination 

Survey, What We Eat in America 

(NHANES/WWEIA). As to residue levels 

in food, EPA used tolerance level 

residues, assumed 100 percent crop 

treated (PCT), and incorporated DEEM 

default processing factors when 

processing data were not available. 

iii. Cancer. EPA determines whether 

quantitative cancer exposure and risk 

assessments are appropriate for a fooduse pesticide based on the weight of the 

evidence from cancer studies and other 

relevant data. Cancer risk is quantified 

using a linear or nonlinear approach. If 

sufficient information on the 

carcinogenic mode of action is available, 

a threshold or nonlinear approach is 

used and a cancer RfD is calculated 

based on an earlier noncancer key event. 

If carcinogenic mode of action data are 

not available, or if the mode of action 

data determines a mutagenic mode of 

action, a default linear cancer slope 

factor approach is utilized. Based on the 

data summarized in Unit III.A. of the 

Federal Register of March 17, 2010 (75 

FR 12691) (FRL–8813–7), EPA has 

concluded that a nonlinear RfD 

approach is appropriate for assessing 

cancer risk to hexythiazox. Cancer risk 

was assessed using the same exposure 

estimates as discussed in Unit III.C.1.ii., 

chronic exposure. 

iv. Anticipated residue and percent 

crop treated (PCT) information. EPA did 

not use anticipated residue and/or PCT 

information in the dietary assessment 

for hexythiazox. Tolerance level 

residues and/or 100 PCT were assumed 

for all food commodities. 

2. Dietary exposure from drinking 

water. The Agency used screening level 

water exposure models in the dietary 

exposure analysis and risk assessment 

for hexythiazox in drinking water. 

These simulation models take into 

account data on the physical, chemical, 

and fate/transport characteristics of 

hexythiazox. Further information 

regarding EPA drinking water models 

used in pesticide exposure assessment 

can be found at http://www.epa.gov/ 

oppefed1/models/water/index.htm. 

Based on the Pesticide Root Zone 

Model/Exposure Analysis Modeling 

System (PRZM/EXAMS), the estimated 

drinking water concentrations (EDWC) 

of hexythiazox for chronic exposures for 

non-cancer and cancer assessments are 

estimated to be 4.3 ppb for surface 

water. Since surface water residues 

values greatly exceed groundwater 

EDWCs, surface water residues were 

used in the dietary risk assessment. 

Modeled estimates of drinking water 

concentrations were directly entered 

into the dietary exposure model. 

3. From non-dietary exposure. The 

term ‘‘residential exposure’’ is used in 

this document to refer to nonoccupational, non-dietary exposure 

(e.g., for lawn and garden pest control, 

indoor pest control, termiticides, and 

flea and tick control on pets). 

Hexythiazox is currently registered for 

the following uses that could result in 

residential exposures: Ornamental 

plantings, turf, and fruit and nut trees in 

residential settings. EPA assessed 

residential exposure using the following 

assumptions: Residential handler 

exposures are expected to be short-term 

(1 to 30 days) via either the dermal or 

inhalation routes of exposures. Since a 

quantitative dermal risk assessment is 

not needed for hexythiazox; MOEs were 

calculated for the inhalation route of 

exposure only. Both adults and children 

may be exposed to hexythiazox residues 

from contact with treated lawns or 

treated residential plants. Post 

application exposures are expected to be 

short-term (1 to 30 days) and 

intermediate-term (1 to 6 months) in 

duration. Adult postapplication 

exposures were not assessed since no 

quantitative dermal risk assessment is 

needed for hexythiazox and inhalation 

exposures are typically negligible in 

outdoor settings. The exposure 

assessment for children included 

incidental oral exposure resulting from 


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transfer of residues from the hands or 

objects to the mouth, and from 

incidental ingestion of soil. 

Details of the residential exposure and 

risk assessment can be found at http:// 

www.regulations.gov in document 

‘‘Hexythiazox. Human Health Risk 

Assessment to Support New Uses on 

Alfalfa and Timothy’’ in docket ID 

number EPA–HQ–OPP–2010–0916. 

Further information regarding EPA 

standard assumptions and generic 

inputs for residential exposures may be 

found at http://www.epa.gov/pesticides/ 

trac/science/trac6a05.pdf. 

4. Cumulative effects from substances 

with a common mechanism of toxicity. 

Section 408(b)(2)(D)(v) of FFDCA 

requires that, when considering whether 

to establish, modify, or revoke a 

tolerance, the Agency consider 

‘‘available information’’ concerning the 

cumulative effects of a particular 

pesticide’s residues and ‘‘other 

substances that have a common 

mechanism of toxicity.’’ 

EPA has not found hexythiazox to 

share a common mechanism of toxicity 

with any other substances, and 

hexythiazox does not appear to produce 

a toxic metabolite produced by other 

substances. For the purposes of this 

tolerance action, therefore, EPA has 

assumed that hexythiazox does not have 

a common mechanism of toxicity with 

other substances. For information 

regarding EPA’s efforts to determine 

which chemicals have a common 

mechanism of toxicity and to evaluate 

the cumulative effects of such 

chemicals, see EPA’s Web site at 

http://www.epa.gov/pesticides/ 

cumulative. 

D. Safety Factor for Infants and 

Children 

1. In general. Section 408(b)(2)(C) of 

FFDCA provides that EPA shall apply 

an additional tenfold (10X) margin of 

safety for infants and children in the 

case of threshold effects to account for 

prenatal and postnatal toxicity and the 

completeness of the database on toxicity 

and exposure unless EPA determines 

based on reliable data that a different 

margin of safety will be safe for infants 

and children. This additional margin of 

safety is commonly referred to as the 

FQPA Safety Factor (SF). In applying 

this provision, EPA either retains the 

default value of 10X, or uses a different 

additional safety factor when reliable 

data available to EPA support the choice 

of a different factor. 

2. Prenatal and postnatal sensitivity. 

The prenatal and postnatal toxicology 

data base indicates no increased 

susceptibility of rats or rabbits to in 

utero and/or postnatal exposure to 

hexythiazox. 

3. Conclusion. EPA has determined 

that reliable data show the safety of 

infants and children would be 

adequately protected if the FQPA SF 

were reduced to 1X. That decision is 

based on the following findings: 

i. The toxicity database for 

hexythiazox is complete. 

ii. There is no indication that 

hexythiazox is a neurotoxic chemical 

and there is no need for a 

developmental neurotoxicity study or 

additional UFs to account for 

neurotoxicity. 

iii. There is no evidence that 

hexythiazox results in increased 

susceptibility in in utero rats or rabbits 

in the prenatal developmental studies or 

in young rats in the 2-generation 

reproduction study. 

iv. There are no residual uncertainties 

identified in the exposure databases. 

The dietary food exposure assessments 

were performed based on 100 PCT and 

tolerance-level residues. The dietary 

risk assessment is highly conservative 

and not expected to underestimate risk. 

EPA made conservative (protective) 

assumptions in the ground and surface 

water modeling used to assess exposure 

to hexythiazox in drinking water. EPA 

used similarly conservative assumptions 

to assess postapplication exposure of 

children as well as incidental oral 

exposure of toddlers. These assessments 

will not underestimate the exposure and 

risks posed by hexythiazox. 

E. Aggregate Risks and Determination of 

Safety 

EPA determines whether acute and 

chronic dietary pesticide exposures are 

safe by comparing aggregate exposure 

estimates to the acute PAD (aPAD) and 

chronic PAD (cPAD). For linear cancer 

risks, EPA calculates the lifetime 

probability of acquiring cancer given the 

estimated aggregate exposure. Short-, 

intermediate-, and chronic-term risks 

are evaluated by comparing the 

estimated aggregate food, water, and 

residential exposure to the appropriate 

PODs to ensure that an adequate MOE 

exists. 

1. Acute risk. An acute aggregate risk 

assessment takes into account acute 

exposure estimates from dietary 

consumption of food and drinking 

water. No adverse effect resulting from 

a single oral exposure was identified 

and no acute dietary endpoint was 

selected. Therefore, hexythiazox is not 

expected to pose an acute risk. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that chronic exposure to hexythiazox 

from food and water will utilize 63% of 

the cPAD for children 1–2 years of age, 

the population group receiving the 

greatest exposure. Based on the 

explanation in Unit III.C.3., regarding 

residential use patterns, chronic 

residential exposure to residues of 

hexythiazox is not expected. 

3. Short-term risk. Short-term 

aggregate exposure takes into account 

short-term residential exposure plus 

chronic exposure to food and water 

(considered to be a background 

exposure level). 

Hexythiazox is currently registered for 

uses that could result in short-term 

residential exposure, and the Agency 

has determined that it is appropriate to 

aggregate chronic exposure through food 

and water with short-term residential 

exposures to hexythiazox. 

Using the exposure assumptions 

described in this unit for short-term 

exposures, EPA has concluded the 

combined short-term food, water, and 

residential exposures result in aggregate 

MOEs of 12,000 for adults and 1,600 for 

children. Because EPA’s level of 

concern for hexythiazox is a MOE of 100 

or below, these MOEs are not of 

concern. 

4. Intermediate-term risk. 

Intermediate-term aggregate exposure 

takes into account intermediate-term 

residential exposure plus chronic 

exposure to food and water (considered 

to be a background exposure level). 

Hexythiazox is currently registered for 

uses that could result in intermediateterm residential exposure, and the 

Agency has determined that it is 

appropriate to aggregate chronic 

exposure through food and water with 

intermediate-term residential exposures 

to hexythiazox. 

Using the exposure assumptions 

described in this unit for intermediateterm exposures, EPA has concluded that 

the combined intermediate-term food, 

water, and residential exposures result 

in aggregate MOEs of 12,000 for adults 

and 1,900 for children. Because EPA’s 

level of concern for hexythiazox is a 

MOE of 100 or below, these MOEs are 

not of concern. 

5. Aggregate cancer risk for U.S. 

population. As discussed in Unit III. 

C.1.iii., EPA concluded that regulation 

based on the chronic reference dose will 

be protective for both chronic and 

carcinogenic risks. As noted in this unit 

there is no chronic risks of concern. 

6. Determination of safety. Based on 

these risk assessments, EPA concludes 

that there is a reasonable certainty that 

no harm will result to the general 

population, or to infants and children 

from aggregate exposure to hexythiazox 

residues. 


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IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodology 

(high performance liquid 

chromatography method with UV 

detection (HPLC/UV) is available to 

enforce the tolerance expression. 

The method may be requested from: 

Chief, Analytical Chemistry Branch, 

Environmental Science Center, 701 

Mapes Rd., Ft. Meade, MD 20755–5350; 

telephone number: (410) 305–2905; 

email address: 

residuemethods@epa.gov. 

B. International Residue Limits 

In making its tolerance decisions, EPA 

seeks to harmonize U.S. tolerances with 

international standards whenever 

possible, consistent with U.S. food 

safety standards and agricultural 

practices. EPA considers the 

international maximum residue limits 

(MRLs) established by the Codex 

Alimentarius Commission (Codex), as 

required by FFDCA section 408(b)(4). 

The Codex Alimentarius is a joint 

United Nations Food and Agriculture 

Organization/World Health 

Organization food standards program, 

and it is recognized as an international 

food safety standards-setting 

organization in trade agreements to 

which the United States is a party. EPA 

may establish a tolerance that is 

different from a Codex MRL; however, 

FFDCA section 408(b)(4) requires that 

EPA explain the reasons for departing 

from the Codex level. 

No Canadian or Mexican MRLs have 

been established for residues of 

hexythiazox in plants or livestock. 

There are no codex MRLs established 

for alfalfa or timothy; however, there are 

Code MRLs for livestock at 0.05 ppm in/ 

on the following: edible offal 

(mammalian); mammalian fats (except 

milk fats); milks; milk fats; poultry, 

edible offal; poultry meat (fat). The U.S. 

and Codes residue definitions in both 

plants and livestock are harmonized. 

There is no issue of international 

harmonization with respect to the 

recommended alfalfa, timothy, and egg 

tolerances since there are no established 

international tolerances for these 

commodities. The tolerance for 

livestock meat byproducts is not 

harmonized with Codex as the potential 

hexythiazox residue level in meat 

byproducts may exceed the current 

Codex MRL. 

C. Revisions to Petitioned-for Tolerances 

Based on EPA’s review of the data 

supporting the petition, Gowan 

Company revised their petition (PP 

1F7934) as follows: 

i. By increasing the proposed 

tolerances for alfalfa, forage to 15 ppm; 

alfalfa, hay to 30 ppm; timothy forage to 

40 ppm; and timothy, hay to 40 ppm; 

ii. By deleting the proposed tolerances 

for wheat, forage; wheat, hay; wheat, 

grain; and wheat, straw; 

iii. By adding a request for an increase 

in the established tolerances for cattle, 

fat; goat, fat; horse fat; sheep fat; and 

milk to 0.05 ppm; 

iv. By adding a request for an increase 

in the established tolerances for cattle 

meat byproducts; goat, meat byproducts; 

horse, meat byproducts; and sheep, 

meat byproducts to 0.20 ppm; and 

v. By proposing tolerances for poultry, 

fat; and poultry, meat byproducts at 0.05 

ppm; and egg at 0.01 ppm. 

The Agency concluded that based on 

the residue data, these changes are 

required to support the new uses. The 

increase in the alfalfa and timothy 

tolerances were recommended by the 

Agency as a result of analyzing the 

submitted field trial data for these 

commodities using the OEDC MRL 

(Maximum Residue Limit) calculator. 

The increase in the livestock tolerances 

in fat and meat byproducts of ruminants 

are required due to the increased 

livestock dietary burden expected with 

the new uses on alfalfa and timothy. 

The increase in the ruminant fat and 

milk tolerances are recommended in 

order to account for the increased 

dietary burden to livestock and to be 

harmonized with Codex. Additionally, 

because of the potential increase of 

hexythiazox in the poultry diet, largely 

due to alfalfa use, and based on updated 

maximum reasonably balanced diet 

(MRBD) calculations for poultry, 

tolerances for eggs, poultry fat, and meat 

byproducts are required. 

V. Conclusion 

Therefore, tolerances are established 

for residues of hexythiazox and its 

metabolites containing the (4- 

chlorophenyl)-4-methyl-2-oxo-3- 

thiazolidine moiety, as requested in the 

revised petition. 

VI. Statutory and Executive Order 

Reviews 

This final rule establishes tolerances 

under FFDCA section 408(d) in 

response to a petition submitted to the 

Agency. The Office of Management and 

Budget (OMB) has exempted these types 

of actions from review under Executive 

Order 12866, entitled ‘‘Regulatory 

Planning and Review’’ (58 FR 51735, 

October 4, 1993). Because this final rule 

has been exempted from review under 

Executive Order 12866, this final rule is 

not subject to Executive Order 13211, 

entitled ‘‘Actions Concerning 

Regulations That Significantly Affect 

Energy Supply, Distribution, or Use’’ (66 

FR 28355, May 22, 2001) or Executive 

Order 13045, entitled ‘‘Protection of 

Children from Environmental Health 

Risks and Safety Risks’’ (62 FR 19885, 

April 23, 1997). This final rule does not 

contain any information collections 

subject to OMB approval under the 

Paperwork Reduction Act (PRA) (44 

U.S.C. 3501 et seq.), nor does it require 

any special considerations under 

Executive Order 12898, entitled 

‘‘Federal Actions to Address 

Environmental Justice in Minority 

Populations and Low-Income 

Populations’’ (59 FR 7629, February 16, 

1994). 

Since tolerances and exemptions that 

are established on the basis of a petition 

under FFDCA section 408(d), such as 

the tolerance in this final rule, do not 

require the issuance of a proposed rule, 

the requirements of the Regulatory 

Flexibility Act (RFA) (5 U.S.C. 601 et 

seq.), do not apply. 

This final rule directly regulates 

growers, food processors, food handlers, 

and food retailers, not States or tribes, 

nor does this action alter the 

relationships or distribution of power 

and responsibilities established by 

Congress in the preemption provisions 

of FFDCA section 408(n)(4). As such, 

the Agency has determined that this 

action will not have a substantial direct 

effect on States or tribal governments, 

on the relationship between the national 

government and the States or tribal 

governments, or on the distribution of 

power and responsibilities among the 

various levels of government or between 

the Federal Government and Indian 

tribes. Thus, the Agency has determined 

that Executive Order 13132, entitled 

‘‘Federalism’’ (64 FR 43255, August 10, 

1999) and Executive Order 13175, 

entitled ‘‘Consultation and Coordination 

with Indian Tribal Governments’’ (65 FR 

67249, November 9, 2000) do not apply 

to this final rule. In addition, this final 

rule does not impose any enforceable 

duty or contain any unfunded mandate 

as described under Title II of the 

Unfunded Mandates Reform Act of 1995 

(UMRA) (2 U.S.C. 1501 et seq.). 

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act of 1995 

(NTTAA) (15 U.S.C. 272 note). 

VII. Congressional Review Act 

Pursuant to the Congressional Review 

Act (5 U.S.C. 801 et seq.), EPA will 

submit a report containing this rule and 

other required information to the U.S. 


wreier-aviles on DSK7SPTVN1PROD with RULES
Federal Register / Vol. 78, No. 27 / Friday, February 8, 2013 / Rules and Regulations 9327 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication of the rule in the Federal 

Register. This action is not a ‘‘major 

rule’’ as defined by 5 U.S.C. 804(2). 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: February 4, 2013. 

Lois Rossi, 

Director, Registration Division, Office of 

Pesticide Programs. 

Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

Authority: 21 U.S.C. 321(q), 346a and 371. 

■ 2. Section 180.448 is amended as 

follows: 

■ i. In paragraph (a), in the table, revise 

the entries for ‘‘cattle, fat;’’ ‘‘cattle, meat 

byproducts;’’ ‘‘goat, fat;’’ ‘‘goat, meat 

byproducts;’’ ‘‘horse, fat;’’ ‘‘horse, meat 

byproducts;’’ ‘‘sheep, fat;’’ ‘‘sheep, meat 

byproducts;’’ and ‘‘milk.’’ 

■ ii. In paragraph (a), in the table, add 

entries for ‘‘poultry, fat;’’ ‘‘poultry, meat 

byproducts;’’ and ‘‘egg.’’ 

■ iii. In paragraph (c), in the table, add 

entries for ‘‘alfalfa, forage (EPA Regions 

9–11 only;’’ ‘‘alfalfa, hay (EPA Regions 

9–11 only;’’ ‘‘timothy, forage (EPA 

Regions 9–11 only;’’ and ‘‘timothy, hay 

(EPA Regions 9–11 only.’’ 

The additions and revisions read as 

follows: 

§ 180.448 Hexythiazox; tolerance for 

residues. 

(a) * * * 

Commodity Parts per 

million 

* * * * * 

Cattle, fat .................................... 0.05 

Cattle, meat byproducts ............. 0.20 

* * * * * 

Egg ............................................. 0.01 

* * * * * 

Goat, fat ...................................... 0.05 

Goat, meat byproducts ............... 0.20 

* * * * * 

Horse, fat .................................... 0.05 

Horse, meat byproducts ............. 0.20 

* * * * * 

Milk ............................................. 0.05 

Commodity Parts per 

million 

* * * * * 

Poultry, fat .................................. 0.05 

Poultry, meat byproducts ............ 0.05 

* * * * * 

Sheep, fat ................................... 0.05 

Sheep, meat byproducts ............ 0.20 

* * * * * 

(c) * * * 

Commodity Parts per 

million 

Alfalfa, forage (EPA Regions 9– 

11 only) ................................... 15 

Alfalfa, hay (EPA Regions 9–11 

only) ........................................ 30 

* * * * * 

Timothy, forage (EPA Regions 

9–11 only) ............................... 40 

Timothy, hay (EPA Regions 9– 

11 only) ................................... 40 

* * * * * 

[FR Doc. 2013–02924 Filed 2–7–13; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF COMMERCE 

National Oceanic and Atmospheric 

Administration 

50 CFR Part 665 

RIN 0648–XC453 

Hawaii Crustacean Fisheries; 2013 

Northwestern Hawaiian Islands 

Lobster Harvest Guideline 

AGENCY: National Marine Fisheries 

Service (NMFS), National Oceanic and 

Atmospheric Administration (NOAA), 

Commerce. 

ACTION: Notification of lobster harvest 

guideline. 

SUMMARY: NMFS establishes the annual 

harvest guideline for the commercial 

lobster fishery in the Northwestern 

Hawaiian Islands (NWHI) for calendar 

year 2013 at zero lobsters. 

DATES: February 8, 2013. 

FOR FURTHER INFORMATION CONTACT: 

Jarad Makaiau, NMFS Pacific Islands 

Region, 808–944–2108. 

SUPPLEMENTARY INFORMATION: The NWHI 

commercial lobster fishery is managed 

under the Fishery Ecosystem Plan for 

the Hawaiian Archipelago. The 

regulations at 50 CFR 665.252(b) require 

NMFS to publish an annual harvest 

guideline for lobster Permit Area 1, 

comprised of Federal waters around the 

(NWHI). Regulations governing the 

Papahanaumokuakea Marine National 

Monument in the NWHI prohibit the 

unpermitted removal of monument 

resources (50 CFR 404.7), and establish 

a zero annual harvest guideline for 

lobsters (50 CFR 404.10(a)). 

Accordingly, NMFS establishes the 

harvest guideline for the NWHI 

commercial lobster fishery for calendar 

year 2013 at zero lobsters. Thus, no 

harvest of NWHI lobster resources is 

allowed. 

Authority: 16 U.S.C. 1801 et seq. 

Dated: February 5, 2013. 

Kara Meckley, 

Acting Deputy Director, Office of Sustainable 

Fisheries, National Marine Fisheries Service. 

[FR Doc. 2013–02887 Filed 2–7–13; 8:45 am] 

BILLING CODE 3510–22–P 

DEPARTMENT OF COMMERCE 

National Oceanic and Atmospheric 

Administration 

50 CFR Part 679 

[Docket No. 111213751–2102–02] 

RIN 0648–XC481 

Fisheries of the Exclusive Economic 

Zone Off Alaska; Reallocation of 

Pacific Cod in the Bering Sea and 

Aleutian Islands Management Area 

AGENCY: National Marine Fisheries 

Service (NMFS), National Oceanic and 

Atmospheric Administration (NOAA), 

Commerce. 

ACTION: Temporary rule; reallocation. 

SUMMARY: NMFS is reallocating the 

projected unused amount of Pacific cod 

from vessels using jig gear to catcher 

vessels less than 60 feet (18.3 meters) 

length overall using hook-and-line or 

pot gear in the Bering Sea and Aleutian 

Islands management area. This action is 

necessary to allow the A season 

apportionment of the 2013 total 

allowable catch of Pacific cod to be 

harvested. 

DATES: Effective February 5, 2013, 

through 2400 hours, Alaska local time 

(A.l.t.), December 31, 2013. 

FOR FURTHER INFORMATION CONTACT: 

Obren Davis, 907–586–7228. 

SUPPLEMENTARY INFORMATION: NMFS 

manages the groundfish fishery in the 

Bering Sea and Aleutian Islands (BSAI) 

according to the Fishery Management 

Plan for Groundfish of the Bering Sea 

and Aleutian Islands Management Area 

(FMP) prepared by the North Pacific 

Fishery Management Council under 

authority of the Magnuson-Stevens 

Fishery Conservation and Management 


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